[Federal Register Volume 71, Number 185 (Monday, September 25, 2006)]
[Rules and Regulations]
[Pages 55729-55737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8166]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 807, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886,
and 892
[Docket No. 2006N-0335]
Medical Devices; Reprocessed Single-Use Devices; Requirement for
Submission of Validation Data
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
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SUMMARY: The Food and Drug Administration (FDA or we) is amending
certain classification regulations for reprocessed single-use devices
(SUDs) whose exemption from premarket notification (510(k))
requirements have been terminated and other reprocessed SUDs already
subject to premarket notification for which validation data, as
specified under the Medical Device User Fee and Modernization Act of
2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of
the Federal Register, we are publishing a companion proposed rule,
under FDA's usual procedures for notice and comment, to provide a
procedural framework to finalize the rule in the event we receive any
significant adverse comment and withdraw the direct final rule. This
action codifies actions taken in previous Federal Register notices in
accordance with MDUFMA.
DATES: This rule is effective February 7, 2007. Submit written or
electronic comments by December 11, 2006. If we receive no significant
adverse comments within the specified comment period, we intend to
publish a document confirming the effective date of the final rule in
the Federal Register within 30 days after the comment period on this
direct final rule ends. If we receive any timely significant adverse
comment, we will withdraw this final rule in part or in whole by
publication of a document in the Federal Register within 30 days after
the comment period ends.
ADDRESSES: You may submit comments, identified by Docket No. 2006N-
0335, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
[[Page 55730]]
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described in the
Electronic Submissions portion of this paragraph.
Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided. For
additional information on submitting comments, see the ``Comments''
heading of the SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number(s), found in brackets in the heading of
this document, into the ``Search'' box and follow the prompts and/or go
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for
Devices and Radiological Health (HFZ-404), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1190, ext. 143.
SUPPLEMENTARY INFORMATION:
I. What Is the Background of the Rule?
On October 26, 2002, MDUFMA (Public Law 107-250), amended the
Federal Food, Drug, and Cosmetic Act (the act) by adding section 510(o)
(21 U.S.C. 360(o)), which provided new regulatory requirements for
reprocessed SUDs. According to this provision, in order to ensure that
reprocessed SUDs are substantially equivalent to predicate devices,
510(k)s for certain reprocessed SUDs identified by FDA must include
validation data. These required validation data include cleaning and
sterilization data, and functional performance data demonstrating that
each SUD will remain substantially equivalent to its predicate device
after the maximum number of times the device is reprocessed as intended
by the person submitting the premarket notification.
Before enactment of the new law, a manufacturer of a reprocessed
SUD was required to obtain premarket approval or premarket clearance
for the device, unless the device was exempt from premarket submission
requirements. Under MDUFMA, some previously exempt reprocessed SUDs are
no longer exempt from premarket notification requirements.
Manufacturers of these identified devices were required to submit
510(k)s that included validation data specified by FDA. Reprocessors of
certain SUDs already subject to cleared 510(k)s were also required to
submit the validation data specified by the agency.
A. Definitions
Under section 201(ll)(2)(A) of the act (21 U.S.C. 321(ll)(2)(A)), a
reprocessed SUD is defined as an ``original device that has previously
been used on a patient and has been subjected to additional processing
and manufacturing for the purpose of an additional single use on a
patient. The subsequent processing and manufacture of a reprocessed
single-use device shall result in a device that is reprocessed within
the meaning of this definition.'' FDA is amending Sec. 807.3 (21 CFR
807.3) by adding paragraph (t) to incorporate this definition into the
regulations.
Reprocessed SUDs are divided into three groups: (1) Critical, (2)
semicritical, and (3) noncritical. The first two categories are set
forth in the act and all three reflect a categorization scheme
recognized in the industry (Ref. 1). In the Federal Register of April
30, 2003 (68 FR 23139), FDA describes in more detail the development of
this scheme and its use in the implementation of section 510(o) of the
act. The act defines critical and semicritical reprocessed single use
devices at section 201(mm) as amended by MDUFMA. FDA defined
noncritical devices in the Federal Register of April 30, 2003. The
definitions are as follows:
A critical reprocessed SUD is intended to contact normally
sterile tissue or body spaces during use.
A semicritical reprocessed SUD is intended to contact
intact mucous membranes and not penetrate normally sterile areas of the
body.
A noncritical reprocessed SUD is intended to make topical
contact and not penetrate intact skin.
B. Critical and Semicritical Reprocessed SUDs Previously Exempt from
Premarket Notification
MDUFMA required FDA to review the critical and semicritical
reprocessed SUDs that were previously exempt from premarket
notification requirements and determine which of these devices required
premarket notification to ensure their substantial equivalence to
predicate devices. Under MDUFMA, FDA was required to identify in a
Federal Register notice those critical reprocessed SUDs whose exemption
from premarket notification would be terminated and for which FDA
determined that validation data, as specified under MDUFMA, was
necessary in a 510(k). FDA published a list of these devices on April
30, 2003. According to the law, manufacturers of the devices whose
exemptions from premarket notification were terminated were required to
submit 510(k)s that included validation data regarding cleaning,
sterilization, and functional performance, in addition to all the other
required elements of a 510(k) identified in Sec. 807.87 (21 CFR
807.87), within 15 months of publication of the notice or no longer
market their devices.
In accordance with section 510(o) of the act, FDA must revise the
list of devices subject to this requirement as appropriate. In the
Federal Register of June 26, 2003 (68 FR 38071), FDA recategorized nine
device types from semicritical to critical, and added nonelectric
gastroenterology-urology biopsy forceps to the list of critical
reprocessed SUDs whose exemption from premarket notification
requirements was being terminated. In the Federal Register of September
29, 2005 (70 FR 56911), FDA announced that it was adding devices to the
list of critical reprocessed SUDs whose 510(k) exemption is terminated
and for which validation data is necessary.
By April 26, 2004, FDA was required to identify in a Federal
Register notice those semicritical reprocessed SUDs whose exemption
from premarket notification would be terminated and for which FDA
determined that validation data, as specified under MDUFMA, was
necessary in a 510(k). FDA published this list in the Federal Register
of April 13, 2004 (69 FR 19433). As discussed previously in this
document, manufacturers of the devices whose exemptions from premarket
notification were terminated were required to submit 510(k)s that
included validation data regarding cleaning, sterilization, and
functional performance, in addition to all the other required elements
of a 510(k) identified
[[Page 55731]]
in Sec. 807.87, within 15 months of publication of the notice or no
longer market their devices. In accordance with section 510(o) of the
act, FDA must revise the list of devices subject to this requirement as
appropriate.
C. Reprocessed SUDs Already Subject to Premarket Notification
Requirements
MDUFMA also required FDA to review the types of reprocessed SUDs
already subject to premarket notification requirements and to identify
which of these devices required the submission of validation data to
ensure their substantial equivalence to predicate devices. FDA
published a list of these devices in the Federal Register of April 30,
2003. As described previously in this document, FDA must revise the
list of devices subject to this requirement as appropriate. In the
Federal Register of September 29, 2005, FDA announced that it was
adding laparoscopic and endoscopic electrosurgical accessories to this
list of reprocessed SUDs already subject to premarket notification.
For devices identified on this list that had already been cleared
through the 510(k) process, manufacturers were required to submit
validation data regarding cleaning, sterilization, and functional
performance within 9 months of publication of the list or no longer
market their devices.
For devices on this list that were not yet cleared through the
510(k) process, manufacturers were required to submit 510(k)s with
validation data regarding cleaning, sterilization, and functional
performance, in addition to all the other required elements identified
in Sec. 807.87.
II. What Does This Direct Final Rulemaking Do?
In this final rule, FDA is:
Amending Sec. 807.3 to add definitions for ``single use
device,'' ``reprocessed single use device (SUD)'' and ``validation
data.'' The definitions of single use device and reprocessed single use
device reflect the definitions of those terms in section 201(ll) of the
act as amended by MDUFMA. The definition of validation data tracks the
language used to describe validation data in section 510(o)(1)(A) of
the act.
Amending Sec. 807.87 (Information required in a premarket
notification submission) to reference the requirement (of section
510(o) of the act) to submit validation data for reprocessed SUDs in
appropriate situations.
Amending the classification regulations for devices for
which FDA has revoked the exemption from premarket notification
submission for reprocessed SUDs that require the submission of
validation data. If the revocation applies only to a subset within a
generic type, FDA has revised the language accordingly.
Amending the classification regulations for devices
already subject to premarket notification that FDA has designated as
requiring the submission of validation data. If the requirement to
submit validation data applies only to a subset of the generic type,
FDA has revised the regulation accordingly.
Making minor corrections to the classification
regulations, including amending the sections for affected class II
devices to update the definition of class II from requiring
``performance standards'' to requiring ``special controls'' in order to
provide a reasonable assurance of the safety and effectiveness of the
device. This conforms these sections to the definition of class II at
section 513(a)(1)(B) of the act (21 U.S.C. 360c(a)(1)(B)), as revised
by the Safe Medical Devices Act of 1990 (SMDA) (Public Law 101-629).
FDA has made available previously a guidance document on the
submission of validation data entitled ``Medical Device User Fee and
Modernization Act of 2002, Validation Data in Premarket Notification
Submissions (510(k)s) for Reprocessed Single-Use Medical Devices''
(June 1, 2004, 69 FR 30943). This guidance document may be accessed on
the Internet at http://www.fda.gov/cdrh/ode/guidance/1216.html.
III. What are the Procedures for Issuing a Direct Final Rule?
In the Federal Register of November 21, 1997 (62 FR 62466), FDA
announced the availability of the guidance document entitled ``Guidance
for FDA and Industry: Direct Final Rule Procedures'' that described
when and how FDA will employ direct final rulemaking. We believe that
this rule is appropriate for direct final rulemaking because it is
intended to make noncontroversial amendments and minor corrections to
existing regulations. We anticipate no significant adverse comment.
Consistent with FDA's procedures on direct final rulemaking, we are
publishing elsewhere in this issue of the Federal Register a companion
proposed rule that is identical to the direct final rule. The companion
proposed rule provides a procedural framework within which the rule may
be finalized in the event the direct final rule is withdrawn because of
any significant adverse comment. The comment period for this direct
final rule runs concurrently with the comment period of the companion
proposed rule. Any comments received in response to the companion
proposed rule will also be considered as comments regarding this direct
final rule.
If we receive any significant adverse comment, we intend to
withdraw this final rule before its effective date by publication of a
notice in the Federal Register within 30 days after the comment period
ends. A significant adverse comment is defined as a comment that
explains why the rule would be inappropriate, including challenges to
the rule's underlying premise or approach, or would be ineffective or
unacceptable without change. In determining whether an adverse comment
is significant and warrants terminating a direct final rulemaking, we
will consider whether the comment raises an issue serious enough to
warrant a substantive response in a notice-and-comment process in
accordance with section 553 of the Administrative Procedure Act (APA)
(5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside
the scope of the rule will not be considered significant or adverse
under this procedure. For example, a comment recommending an additional
change to the rule will not be considered a significant adverse
comment, unless the comment states why the rule would be ineffective
without the additional change. In addition, if a significant adverse
comment applies to part of a rule and that part can be severed from the
remainder of the rule, we may adopt as final those parts of the rule
that are not the subject of a significant adverse comment.
If we withdraw the direct final rule, all comments received will be
considered under the companion proposed rule in developing a final rule
under the usual notice-and-comment procedures under the APA (5 U.S.C.
552a et seq.). If we receive no significant adverse comment during the
specified comment period, we intend to publish a confirmation document
in the Federal Register within 30 days after the comment period ends.
IV. What is the Legal Authority for This Rule?
This direct final rule is authorized by sections 201, 301, 501,
502, 510, 513, 515, 519, 520, 701, 704, 801, and 903 of the act and
sections 264 and 271 of the Public Health Service Act (21 U.S.C. 321,
331, 351, 352, 360, 360c, 360e, 360i, 360j, 371, 374, 381, 393; 42
U.S.C. 264 and 271).
[[Page 55732]]
V. What is the Environmental Impact of This Rule?
We have determined under 21 CFR 25.30(h) and 25.34(a) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VI. What is the Economic Impact of This Rule?
We have examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). We believe that this
direct final rule is not a significant regulatory action as defined by
the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this regulation only codifies in regulations
existing statutory requirements, the agency certifies that the final
rule will not have a significant economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $118 million, using the most current (2004) Implicit
Price Deflator for the Gross Domestic Product. We do not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
VII. How Does the Paperwork Reduction Act of 1995 Apply to This Rule?
This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
The collections of information addressed in the direct final rule have
been approved by OMB in accordance with the PRA under the regulations
governing premarket notifications (21 CFR part 807, OMB control number
0910-0120).
VIII. What are the Federalism Impacts of This Rule?
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, we have concluded that the
rule does not contain policies that have federalism implications as
defined in the Executive order and, consequently, a federalism summary
impact statement is not required.
IX. How Do You Submit Comments on This Rule?
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this direct
final rule. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
X. What Is the Reference for This Rule?
The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 am. and 4 pm., Monday through Friday.
1. Spaulding, E. H., ``The Role of Chemical Disinfection in the
Prevention of Nonsocomial Infections.'' Edited by P. S. Brachman and
T. C. Eickof, Proceedings of International Conference on Nonsocomial
Infections, 1970, American Hospital Association, Chicago, 254-274,
1971.
List of Subjects
21 CFR Part 807
Confidential business information, Imports, Medical devices,
Reporting and recordkeeping requirements.
21 CFR Parts 868, 870, 872, 874, 876, 878, 880, 882, and 884
Medical devices.
21 CFR Part 886
Medical devices, Opthalmic goods and services.
21 CFR Part 892
Medical devices, Radiation protection, X-rays.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
807, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, and 892 are
amended as follows:
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
0
1. The authority citation for 21 CFR part 807 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i,
360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.
0
2. Section 807.3 is amended by adding new paragraphs (t), (u), and (v)
to read as follows:
Sec. 807.3 Definitions.
* * * * *
(t) A single use device (SUD) means a device that is intended for
one use or on a single patient during a single procedure.
(u) A reprocessed SUD is an original device that has previously
been used on a patient and has been subjected to additional processing
and manufacturing for the purpose of an additional single use on a
patient. The subsequent processing and manufacture of a reprocessed SUD
shall result in a device that is reprocessed within the meaning of this
definition.
(v) Validation data for the purposes of this part means cleaning
and sterilization data, and functional performance data demonstrating
that an SUD will remain substantially equivalent to its predicate
device after the maximum number of times the device is reprocessed as
intended by the person submitting the premarket notification.
0
3. Section 807.87 is amended by redesignating paragraphs (h), (i), (j),
(k), and (l) as paragraphs (i), (j), (k), (l), and (m), respectively,
and by adding new paragraph (h) to read as follows:
Sec. 807.87 Information required in a premarket notification
submission.
* * * * *
(h) If the device is a reprocessed SUD that FDA has identified as
requiring validation data, the premarket
[[Page 55733]]
notification submission must include validation data as defined in
Sec. 807.3(v).
* * * * *
PART 868--ANESTHESIOLOGY DEVICES
0
4. The authority citation for 21 CFR part 868 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
5. Section 868.5150 is amended by revising paragraph (b) to read as
follows:
Sec. 868.5150 Anesthesia conduction needle.
* * * * *
(b) Classification. Class II (special controls). If the device is
an anesthetic conduction needle (with/without introducer) or a short
term spinal needle and it is a reprocessed single use device (SUD) as
defined in Sec. 807.3(u) of this chapter, a premarket notification
submission for the device must include validation data as described in
Sec. 807.3(v).
0
6. Section 868.5730 is amended by revising paragraph (b) to read as
follows:
Sec. 868.5730 Tracheal tube.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
0
7. Section 868.5905 is amended by revising paragraph (b) to read as
follows:
Sec. 868.5905 Noncontinuous ventilator (IPPB).
* * * * *
(b) Classification. Class II (special controls). If the device is a
noncontinuous ventilator (respirator) mask that is a reprocessed single
use device (SUD) as defined in Sec. 807.3(u) of this chapter, a
premarket notification submission for the device must include
validation data as described in Sec. 807.3(v).
0
8. Section 868.6810 is amended by revising paragraph (b) to read as
follows:
Sec. 868.6810 Tracheobronchial suction catheter.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 868.9. If the
device is a reprocessed single use device (SUD) as defined in Sec.
807.3(u) of this chapter, the exemption from premarket notification
does not apply and the manufacturer must submit a premarket
notification that includes validation data as described in Sec.
807.3(v).
PART 870--CARDIOVASCULAR DEVICES
0
9. The authority citation for 21 CFR part 870 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
10. Section 870.1200 is amended by revising paragraph (b) to read as
follows:
Sec. 870.1200 Diagnostic intravascular catheter.
* * * * *
(b) Classification. Class II (special controls). If the device is
an angiography catheter that is a reprocessed single use device (SUD)
as defined in Sec. 807.3(u) of this chapter, a premarket notification
submission for the device must include validation data as described in
Sec. 807.3(v).
0
11. Section 870.1220 is amended by revising paragraph (b) to read as
follows:
Sec. 870.1220 Electrode recording catheter or electrode recording
probe.
* * * * *
(b) Classification. Class II (special controls). If the device is
an electrode recording catheter or intracardiac mapping catheter that
is a reprocessed single use device (SUD) as defined in Sec. 807.3(u)
of this chapter, a premarket notification submission for the device
must include validation data as described in Sec. 807.3(v).
0
12. Section 870.1230 is amended by revising paragraph (b) to read as
follows:
Sec. 870.1230 Fiberoptic oximeter catheter.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
0
13. Section 870.1280 is amended by revising paragraph (b) to read as
follows:
Sec. 870.1280 Steerable catheter.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
0
14. Section 870.1290 is amended by revising paragraph (b) to read as
follows:
Sec. 870.1290 Steerable catheter control system.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
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15. Section 870.1330 is amended by revising paragraph (b) to read as
follows:
Sec. 870.1330 Catheter guide wire.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
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16. Section 870.1390 is amended by revising paragraph (b) to read as
follows:
Sec. 870.1390 Trocar.
* * * * *
(b) Classification. Class II (special controls). If the device is a
cardiovascular trocar that is a reprocessed single use device (SUD) as
defined in Sec. 807.3(u) of this chapter, a premarket notification
submission for the device must include validation data as described in
Sec. 807.3(v).
17. Section 870.1650 is amended by revising paragraph (b) to read
as follows:
Sec. 870.1650 Angiographic injector and syringe.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
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18. Section 870.1670 is amended by revising paragraph (b) to read as
follows:
Sec. 870.1670 Syringe actuator for an injector.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
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19. Section 870.2700 is amended by revising paragraph (b) to read as
follows:
Sec. 870.2700 Oximeter.
* * * * *
(b) Classification. Class II (special controls). If the device is a
tissue saturation oximeter or an oximeter and it is a reprocessed
single use device (SUD) as defined in Sec. 807.3(u) of this chapter, a
premarket notification submission for the device must include
[[Page 55734]]
validation data as described in Sec. 807.3(v).
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20. Section 870.3535 is amended by revising paragraph (b) to read as
follows:
Sec. 870.3535 Intra-aortic balloon and control system.
* * * * *
(b) Classification. Class III (premarket approval). If the device
is a reprocessed single use device (SUD) as defined in Sec. 807.3(u)
of this chapter, a premarket notification submission for the device
must include validation data as described in Sec. 807.3(v).
* * * * *
0
21. Section 870.4450 is amended by revising paragraph (b) to read as
follows:
Sec. 870.4450 Vascular clamp.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
0
22. Section 870.4500 is amended by revising paragraph (b) to read as
follows:
Sec. 870.4500 Cardiovascular surgical instruments.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 870.9. If the
device is a noncompression heart stabilizer that is a reprocessed
single use device (SUD) as defined in Sec. 807.3(u) of this chapter,
the exemption from premarket notification does not apply and the
manufacturer must submit a premarket notification that includes
validation data as described in Sec. 807.3(v).
0
23. Section 870.4885 is amended by revising paragraph (b) to read as
follows:
Sec. 870.4885 External vein stripper.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
PART 872--DENTAL DEVICES
0
24. The authority citation for 21 CFR part 872 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
25. Section 872.3240 is amended by revising paragraph (b) to read as
follows:
Sec. 872.3240 Dental bur.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 872.9. If the
device is a dental diamond coated bur that is a reprocessed single use
device (SUD) as defined in Sec. 807.3(u) of this chapter, the
exemption from premarket notification does not apply and the
manufacturer must submit a premarket notification submission that
includes validation data as described in Sec. 807.3(v).
0
26. Section 872.4535 is amended by revising paragraph (b) to read as
follows:
Sec. 872.4535 Dental diamond instrument.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 872.9. If the
device is a reprocessed single use device (SUD) as defined in Sec.
807.3(u) of this chapter, the exemption from premarket notification
does not apply and the manufacturer must submit a premarket
notification that includes validation data as described in Sec.
807.3(v).
0
27. Section 872.4730 is amended by revising paragraph (b) to read as
follows:
Sec. 872.4730 Dental injecting needle.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 872.9. If the
device is a reprocessed single use device (SUD) as defined in Sec.
807.3(u) of this chapter, the exemption from premarket notification
does not apply and the manufacturer must submit a premarket
notification that includes validation data as described in Sec.
807.3(v).
0
28. Section 872.5410 is amended by revising paragraph (b) to read as
follows:
Sec. 872.5410 Orthodontic appliance and accessories.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 872.9. If the
device is a orthodontic metal bracket that is a reprocessed single use
device (SUD) as defined in Sec. 807.3(u) of this chapter, the
exemption from premarket notification does not apply and the
manufacturer must submit a premarket notification that includes
validation data as described in Sec. 807.3(v).
0
29. Section 872.5470 is amended by revising paragraph (b) to read as
follows:
Sec. 872.5470 Orthodontic plastic bracket.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, the exemption from premarket notification does not apply
and the manufacturer must submit a premarket notification that includes
validation data as described in Sec. 807.3(v).
PART 874--EAR, NOSE, AND THROAT DEVICES
0
30. The authority citation for 21 CFR part 874 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
31. Section 874.4140 is amended by revising paragraph (b) to read as
follows:
Sec. 874.4140 Ear, nose, and throat bur.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 874.9. If the
device is an ear, nose, and throat (ENT) high speed microdebrider or an
ENT diamond coated bur and it is a reprocessed single use device (SUD)
as defined in Sec. 807.3(u) of this chapter, the exemption from
premarket notification does not apply and the manufacturer must submit
a premarket notification that includes validation data as described in
Sec. 807.3(v).
0
32. Section 874.4420 is amended by revising paragraph (b) to read as
follows:
Sec. 874.4420 Ear, nose, and throat manual surgical instrument.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 874.9. If the
device is a laryngeal, sinus, or tracheal trocar that is a reprocessed
single use device (SUD) as defined in Sec. 807.3(u) of this chapter,
the exemption from premarket notification does not apply and the
manufacturer must submit a premarket notification that includes
validation data as described in Sec. 807.3(v).
0
33. Section 874.4680 is amended by revising paragraph (b) to read as
follows:
[[Page 55735]]
Sec. 874.4680 Bronchoscope (flexible or rigid) and accessories.
* * * * *
(b) Classification. Class II (special controls). If the device is a
bronchoscope (nonrigid) biopsy forceps that is a reprocessed single use
device (SUD) as defined in Sec. 807.3(u) of this chapter, a premarket
notification submission for the device must include validation data as
described in Sec. 807.3(v).
PART 876--GASTROENTEROLOGY-UROLOGY DEVICES
0
34. The authority citation for 21 CFR part 876 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
35. Section 876.1075 is amended by revising paragraph (b) to read as
follows:
Sec. 876.1075 Gastroenterology-urology biopsy instrument.
* * * * *
(b) Classification. (1) Class II (special controls). If the device
is a gastroenterology-urology (G-U) biopsy needle and needle set or a
biopsy instrument and it is a reprocessed single use device (SUD) as
defined in Sec. 807.3(u) of this chapter, a premarket notification
submission for the device must include validation data as described in
Sec. 807.3(v).
(2) Class I (general controls) for the biopsy forceps cover and the
non-electric biopsy forceps. The devices subject to this paragraph
(b)(2) are exempt from the premarket notification procedures in subpart
E of part 807 of this chapter subject to the limitations in Sec.
876.9. If the device is a non-electric biopsy forceps that is a
reprocessed SUD as defined in Sec. 807.3(u) of this chapter, the
exemption from premarket notification does not apply and the
manufacturer must submit a premarket notification that includes
validation data as described in Sec. 807.3(v).
0
36. Section 876.1500 is amended by revising paragraph (b) (1) to read
as follows:
Sec. 876.1500 Endoscope and accessories.
* * * * *
(b) Classification. (1) Class II (special controls). If the device
is an endoscopic needle, an endoilluminator, a general and plastic
surgery laparoscope, or a spring-loaded pneumoperitoneum needle and it
is a reprocessed single use device (SUD) as defined in Sec. 807.3(u)
of this chapter, a premarket notification submission for the device
must include validation data as described in Sec. 807.3(v).
* * * * *
0
37. Section 876.4300 is amended by revising paragraph (b) to read as
follows:
Sec. 876.4300 Endoscopic electrosurgical unit and accessories.
* * * * *
(b) Classification. Class II (special controls). If the device is
an active urological electrosurgical electrode, a flexible suction
coagulator electrode, an electric biopsy forceps, a flexible snare, or
an endoscopic (with or without accessories) electrosurgical unit that
is a reprocessed single use device (SUD) as defined in Sec. 807.3(u)
of this chapter, a premarket notification submission for the device
must include validation data as described in Sec. 807.3(v).
0
38. Section 876.4680 is amended by revising paragraph (b) to read as
follows:
Sec. 876.4680 Ureteral stone dislodger.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 876.9. If the
device is a flexible and basket stone dislodger that is a reprocessed
single use device (SUD) as defined in Sec. 807.3(u) of this chapter, a
premarket notification submission for the device must include
validation data as described in Sec. 807.3(v).
0
39. Section 876.5010 is amended by revising paragraph (b) to read as
follows:
Sec. 876.5010 Biliary catheter and accessories.
* * * * *
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 876.9. If the
device is a biliary catheter that is a reprocessed single use device
(SUD) as defined in Sec. 807.3(u) of this chapter, a premarket
notification submission for the device must include validation data as
described in Sec. 807.3(v).
0
40. Section 876.5540 is amended in paragraph (b) (3) to read as
follows:
Sec. 876.5540 Blood access device and accessories.
* * * * *
(b) * * *
(3) Class II (special controls) for accessories for both the
implanted and the nonimplanted blood access devices not listed in
paragraph (b)(4) of this section. If the device is a single needle
dialysis set (coaxial flow) or fistula needle and it is a reprocessed
single use device (SUD) as defined in Sec. 807.3(u) of this chapter, a
premarket notification submission for the device must include
validation data as described in Sec. 807.3(v).
* * * * *
0
41. Section 876.5820 is amended by revising paragraph (b) (1) to read
as follows:
Sec. 876.5820 Hemodialysis system and accessories.
* * * * *
(b) Classification. (1) Class II (special controls) (for
hemodialysis systems and all accessories directly associated with the
extracorporeal blood system and the dialysate delivery system). If the
device is a single needle dialysis set with uni-directional pump that
is a reprocessed single use device (SUD) as defined in Sec. 807.3(u)
of this chapter, a premarket notification submission for the device
must include validation data as described in Sec. 807.3(v).
* * * * *
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
0
42. The authority citation for 21 CFR part 878 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
43. Section 878.4200 is amended by revising paragraph (b) to read as
follows:
Sec. 878.4200 Introduction/drainage catheter and accessories.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 878.9. If the
device is a catheter needle that is a reprocessed single use device
(SUD) as defined in Sec. 807.3(u) of this chapter, the exemption from
premarket notification does not apply and the manufacturer must submit
a premarket notification that includes validation data as described in
Sec. 807.3(v).
0
44. Section 878.4300 is amended by revising paragraph (b) to read as
follows:
Sec. 878.4300 Implantable clip.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
0
45. Section 878.4400 is amended by revising paragraph (b) to read as
follows:
Sec. 878.4400 Electrosurgical cutting and coagulation device and
accessories.
* * * * *
[[Page 55736]]
(b) Classification. Class II (special controls). If the device is
an endoscopic or laparoscopic electrosurgical accessory that is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
0
46. Section 878.4750 is amended by revising paragraph (b) to read as
follows:
Sec. 878.4750 Implantable staple.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
0
47. Section 878.4800 is amended by revising paragraph (b) to read as
follows:
Sec. 878.4800 Manual surgical instrument for general use.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 878.9. If the
device is a percutaneous biopsy device, a gastroenterology-urology
needle, a cardiovascular biopsy needle, or an aspiration and injection
needle and it is a reprocessed single use device (SUD) as defined in
Sec. 807.3(u) of this chapter, the exemption from premarket
notification does not apply and the manufacturer must submit a
premarket notification that includes validation data as described in
Sec. 807.3(v).
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
0
48. The authority citation for 21 CFR part 880 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
49. Section 880.5570 is amended by revising paragraph (b) to read as
follows:
Sec. 880.5570 Hypodermic single lumen needle.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
0
50. Section 880.5860 is amended by revising paragraph (b) to read as
follows:
Sec. 880.5860 Piston syringe.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
PART 882--NEUROLOGICAL DEVICES
0
51. The authority citation for 21 CFR part 882 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
52. Section 882.4190 is amended by revising paragraph (b) to read as
follows:
Sec. 882.4190 Clip forming/cutting instrument.
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in Sec. 882.9. If the
device is a reprocessed single use device (SUD) as defined in Sec.
807.3(u) of this chapter, the exemption from premarket notification
does not apply and the manufacturer must submit a premarket
notification that includes validation data as described in Sec.
807.3(v).
0
53. Section 882.4300 is amended by revising paragraph (b) to read as
follows:
Sec. 882.4300 Manual cranial drills, burrs, trephines, and
accessories.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
0
54. Section 882.4305 is amended by revising paragraph (b) to read as
follows:
Sec. 882.4305 Powered compound cranial drills, burrs, trephines, and
their accessories.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
0
55. Section 882.4310 is amended by revising paragraph (b) to read as
follows:
Sec. 882.4310 Powered simple cranial drills, burrs, trephines, and
their accessories.
* * * * *
(b) Classification. Class II (special controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
0
56. The authority citation for 21 CFR part 884 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
57. Section 884.1720 is amended by revising paragraph (b)(1) to read as
follows:
Sec. 884.1720 Gynecologic laparoscope and accessories.
* * * * *
(b) (1) Classification. Class II (special controls). If the device
is a reprocessed single use device (SUD) as defined in Sec. 807.3(u)
of this chapter, a premarket notification submission for the device
must include validation data as described in Sec. 807.3(v).
* * * * *
0
58. Section 884.1730 is amended by revising paragraph (b)(2) to read as
follows:
Sec. 884.1730 Laparoscopic insufflator.
* * * * *
(b) * * *
(2) Class I for tubing and tubing/filter kits which include
accessory instruments that are not used to effect intra-abdominal
insufflation (pneumoperitoneum). The devices subject to this paragraph
(b)(2) are exempt from the premarket notification procedures in subpart
E of part 807 of this chapter, subject to the limitations in Sec.
884.9. If the device is a reprocessed single use device (SUD) as
defined in Sec. 807.3(u) of this chapter, the exemption from premarket
notification does not apply and the manufacturer must submit a
premarket notification that includes validation data as described in
Sec. 807.3(v).
0
59. Section 884.4530 is amended by revising paragraph (b)(2) to read as
follows:
Sec. 884.4530 Obstetric-gynecologic specialized manual instrument.
* * * * *
(b) * * *
(2) Class I for the amniotome, uterine curette, cervical dilator
(fixed-size bougies), cerclage needle, intrauterine device (IUD)
remover, uterine sound, and gynecological biopsy forceps. The devices
subject to this paragraph (b)(2) are exempt from the premarket
notification procedures in subpart E of part 807 of this chapter,
subject to the limitations in Sec. 884.9. If the device is a
[[Page 55737]]
gynecological biopsy forceps that is a reprocessed single use device
(SUD) as defined in Sec. 807.3(u) of this chapter, the exemption from
premarket notification does not apply and the manufacturer must submit
a premarket notification that includes validation data as described in
Sec. 807.3(v).
0
60. Section 884.6100 is amended by revising paragraph (b) to read as
follows:
Sec. 884.6100 Assisted reproduction needles.
* * * * *
(b) Classification. Class II (special controls) (mouse embryo assay
information, endotoxin testing, sterilization validation, design
specifications, labeling requirements, biocompatibility testing, and
clinical testing). If the device is a reprocessed single use device
(SUD) as defined in Sec. 807.3(u) of this chapter, the exemption from
premarket notification does not apply and the manufacturer must submit
a premarket notification that includes validation data as described in
Sec. 807.3(v).
PART 886--OPTHALMIC DEVICES
0
61. The authority citation for 21 CFR part 886 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
62. Section 886.4350 is amended by revising paragraph (b) to read as
follows:
Sec. 886.4350 Manual ophthalmic surgical instrument .
* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter, subject to the limitations in Sec. 886.9. If the
device is an ophthalmic knife that is a reprocessed single use device
(SUD) as defined in Sec. 807.3(u) of this chapter, the exemption from
premarket notification does not apply and the manufacturer must submit
a premarket notification that includes validation data as described in
Sec. 807.3(v).
0
63. Section 886.4370 is amended by revising paragraph (b) to read as
follows:
Sec. 886.4370 Keratome.
* * * * *
(b) Classification. Class I (general controls). If the device is a
reprocessed single use device (SUD) as defined in Sec. 807.3(u) of
this chapter, a premarket notification submission for the device must
include validation data as described in Sec. 807.3(v).
0
64. Section 886.4670 is amended by revising paragraph (b) to read as
follows:
Sec. 886.4670 Phacofragmentation system.
* * * * *
(b) Classification. Class II (special controls). If the device is a
phacoemulsification needle that is a reprocessed single use device
(SUD) as defined in Sec. 807.3(u) of this chapter, a premarket
notification submission for the device must include validation data as
described in Sec. 807.3(v).
PART 892--RADIOLOGY DEVICES
0
65. The authority citation for 21 CFR part 892 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
66. Section 892.5730 is amended by revising paragraph (b) to read as
follows:
Sec. 892.5730 Radionuclide brachytherapy source.
* * * * *
(b) Classification. Class II (special controls). If the device is
an isotope needle that is a reprocessed single use device (SUD) as
defined in Sec. 807.3(u) of this chapter, a premarket notification
submission for the device must include validation data as described in
Sec. 807.3(v).
Dated: September 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-8166 Filed 9-22-06; 8:45 am]
BILLING CODE 4160-01-S